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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05893823
Other study ID # PSOAS IMP
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 6, 2022
Est. completion date September 30, 2024

Study information

Verified date January 2024
Source Istituto Ortopedico Rizzoli
Contact Federica Mariotti, MD
Phone +390516366281
Email federica.mariotti@ior.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to identify radiological factors on TC of the hip that could lead to prediction of development of symptomatic psoas impingement in patients with protruding acetabular cup after primary total hip arthroplasty.


Recruitment information / eligibility

Status Recruiting
Enrollment 48
Est. completion date September 30, 2024
Est. primary completion date June 6, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Primary total hip arthroplasty - Execution of a postoperative Ct scan for pain, noises or planning of the contralateral THA - 5 years minimum follow-up for the control group, tenotomy of the iliopsoas muscle in the cases group - Complete clinical and radiological data Exclusion Criteria: - Patient's refusal to participate - Non adequate Ct scans or made for periprosthetic fractures, component mobilization, periprosthetic infection or wearing of the prosthesis - Incomplete clinical and radiological data - Inadequate follow-up or regression of the iliopsoas impingement symptoms with non-operative treatment

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Pelvis CT scan
Post-THA hip pelvis CT scan execution for pain, noise or THA planning for the controlateral hip, with identification of acetabular cup protrusion. Comparation of cases and controls to identify radiological factors that could potentially lead to symptomatic psoas impingement prediction.

Locations

Country Name City State
Italy Istituto Ortopedico Rizzoli Bologna Emilia Romagna

Sponsors (1)

Lead Sponsor Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Acetabular cup antiversion The angle between the tangent to the cup opening and the tangent to the posterior ischial spines in the axial plane 0
Primary Acetabular cup inclination The angle between the tangent to the cup opening and the interteardrop line in the frontal plane at baseline (day 0)
Primary Femoral offset The distance between the center of rotation and the femoral axis in the frontal plane at baseline (day 0)
Primary Acetabular offset The distance between the center of rotation and the Kohler line in the frontal plane at baseline (day 0)
Primary Eccentric Reaming The distance between the native hip center of rotation and the acetabular cup center of rotation in the axial plane at baseline (day 0)
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